Observational Cohort Study of TachoSil (TC-018-IN)

Nycomed

Status: Completed

Conditions: Blood Loss, Surgical

Treatments: Drug: Fibrinogen (human) + thrombin (human) (TachoSil)

Study type: Observational

Funder types: Industry

Identifiers

NCT00285623

TC-018-IN

Details and patient eligibility

About

The purpose of this study is to collect information, after exposure to TachoSil ®, of all thromboembolic events, immunological events and drug interactions leading to thromboembolic events or major bleeding. In addition, pharmacoeconomic data will be collected.

Enrollment: 3,000 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• All subjects, treated with TachoSil ® by the participating physicians, will be registered with a set of basic data from their already existing data (i.e. no additional diagnostic procedures will be performed).
• Subjects who will provide their written informed consent to use existing data, allow direct access to data and data processing.